Ministry Status: Routine Monitoring and Engagement

Ontario Public Drug Programs

Exceptional Access Program

The Exceptional Access Program (EAP) facilitates patient access to drugs not funded on the Ontario Drug Benefit (ODB) Formulary, or where no listed alternative is available. In order to receive coverage, the patient must be eligible to receive benefits under the Ontario Drug Benefit (ODB) program.

The Executive Officer, on behalf of the ministry, makes funding decisions for drug products covered under the ODB program's EAP based on recommendations and guidelines from the ministry's expert advisory committee, the Committee to Evaluate Drugs (CED). All EAP requests will be considered according to the policies described below to ensure a fair and consistent review of each request. Other modernization initiatives will minimize the impact of the EAP on prescribers and will make the process more transparent to prescribers and patients.

Funding Decision

Typically the CED recommends consideration through EAP for drug products where strong clinical evidence is not available to support efficacy and/or cost-effectiveness, when compared to other drugs already funded through the ODB program.

EAP requests are only considered for a drug or indication which has been approved for funding by the Executive Officer. For manufacturer-initiated reviews, each complete submission undergoes a rigorous review by the CED. The CED then makes recommendations to the Executive Officer as to whether a drug product should be listed as a Formulary benefit or designated as an interchangeable drug product (for generic drugs). The CED also makes recommendations as to whether or not drug products should be available through EAP, and may develop clinical criteria. Please note, the EAP does not consider funding for non-drug products which includes diabetic test strips, medical or assistive devices, natural health products, or nutritional products. Please refer to the ODB formulary for nutritional products and diabetic test strips that are covered on the ODB Program.

The Executive Officer may also request that the CED perform a review and provide a recommendation for a drug or indication in the absence of a manufacturer submission for the purposes of consideration under EAP. Normally, this occurs for indications which have not been approved by Health Canada (i.e., off-label indications). For Health Canada approved indications, the onus is on the manufacturer to submit information to the Ontario Public Drug Programs to request a product review.

Following the CED's review, the Executive Officer makes the final decision regarding the reimbursement of the product.

EAP Criteria

For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. This includes:

funding for continued treatment that was previously supplied through a clinical trial, or paid for by other means (such as a third party payer)Note: First time applications for the funding of ongoing treatments must meet both initial and renewal criteria for the drug being requested (unless otherwise specified)

EAP Application Process: How to Apply

To apply for funding the patient's physician must submit a request to the EAP documenting complete and relevant medical information. This includes providing the clinical rationale for why formulary benefits are not suitable and addressing the clinical circumstances for which the drug is required. All requests are reviewed according to the guidelines and criteria recommended by the CED and approved by the EO. This review includes a thorough assessment of the patient's specific case and circumstances, as provided by the physician, as well as the scientific evidence to support the request. If EAP approval is granted, the coverage period begins as of the effective date and extends only to the specified date.

Reimbursement criteria for EAP Frequently Requested Drugs

When applying through the EAP, physicians can use the Standard Form [Request for an Unlisted Drug Product – Exceptional Access Program (EAP)], or for certain drugs, physicians can use a drug specific electronic form (e-form). These drug specific e-Forms are interactive and criteria-based, to assist physicians in ensuring all of the necessary information is provided and to facilitate a faster response by the ministry.

Form

EAP Drug Request Form Explanation

Standard Form [Request for an Unlisted Drug Product – Exceptional Access Program (EAP)]

EAP Coverage Durations:

For requests that meet EAP criteria and are approved, the effective date of coverage and the expiry date of coverage will be communicated to the physician on the ministry’s response letter.

Physicians should provide a copy of the response letter to the patient and/or the pharmacy as this may help to avoid a gap in treatment should an extension of the request be required.

Effective November 1, 2013, the Exceptional Access Program is aligning the coverage date of approved EAP requests to the date the clinical decision was made or 30 business days from the date the request was received by the program, whichever is shorter. This change in procedure is to recognize that physicians may not submit an EAP request at the same time as the clinical decision to prescribe an unlisted drug is made.

Only eligible approved requests that meet EAP funding criteria at the time it is received by the program will be aligned. For example, alignment will not be provided for requests with a short duration of approval (e.g., an antibiotic, a drug required before surgery); for renewal requests that are approved before the expiry date of existing funding; for requests that do not meet EAP criteria at the time of receipt, for requests made through the Telephone Request Service (TRS); or for requests made through the Compassionate Review Policy (CRP), to name a few situations.

EAP approvals are not guaranteed as requests must meet EAP criteria for funding. Patients who choose to purchase unlisted drugs in advance of an EAP decision are responsible for out-of-pocket costs.

To receive funding through the Ontario Drug Benefit (ODB) Program's Exceptional Access Program, the patient must be ODB-eligible, which includes Ontarians applying to the Trillium Drug Program (TDP). Additionally, only ODB-eligible costs are considered for reimbursement. For example, drug costs over ODB -eligible costs, credit card and banking charges will not be reimbursed.

Provincial Borders Drug Program (PBDP)

The Provincial Borders Drug Program (PBDP), which became effective February 9, 2015, is a public drug program for ODB Program clients who require access to EAP products and whose closest physician is in Manitoba or Quebec. The new program allows Manitoba physicians who are licensed by the College of Physicians and Surgeons of Manitoba (CPSM) and Quebec physicians who are licensed by the Collège des médecins du Québec (CMQ) to submit funding requests on behalf of any ODB client for an EAP product. The drugs, indications and reimbursement criteria covered under the PBDP are identical to those covered under the EAP, and must be dispensed by an Ontario community pharmacy.

Physicians from Manitoba and Quebec can apply on behalf of an ODB client, by completing and submitting the standard "Request for an unlisted Drug Product - Exceptional Access Program (EAP)" application, noting their Manitoba or Quebec license number instead of the required College of Physicians and Surgeons of Ontario (CPSO) number. The request should include all the relevant medical information, including but not limited to the clinical rationale for requesting the unlisted drug and the reasons why covered benefits are not suitable.

The Request for an Unlisted Drug Product Exceptional Access Program application can be found at: submit a request.

Compassionate Review Policy

Where there are rare clinical circumstances in immediately life-, limb-, or organ-threatening conditions, the Executive Officer will also consider requests for drugs or indications in the absence of a final funding decision. Requests must meet the criteria for the Compassionate Review Policy.

To assist physicians making requests under the CRP, a standardized CRP form has been developed. The physicians are encouraged to use these tools to make submissions under the CRP in order to ensure completeness of requests and quicker turnaround time.

Note: Requests for cancer drugs are considered under the Case-by-Case Review Program (CBCRP) which is administered by Cancer Care Ontario (CCO) on behalf of the Ministry of Health and Long-Term Care. The CBCRP considers funding requests for drugs (both oral therapies and injectable drugs) for the treatment of cancer in patients who have a rare clinical circumstance that is immediately life threatening (i.e. death is likely within a matter of months) and who require treatment with an unfunded drug, because there is no other satisfactory and funded treatment. Please refer to the CCO website (www.cancercare.on.ca/cbcrp) for information on the application process, FAQs, eligibility criteria and program policies.

While CCO will administer the CBCRP, the Executive Officer of Ontario Public Drug Programs makes all final funding decisions.

Funding for Drugs being used in Clinical Trials

This section is intended to clarify the circumstances in which EAP funding will be considered for drugs being used within the context of a clinical trial. Generally, the ODB program does not fund drugs being studied under a clinical trial. These costs should be funded by the trial organizer and accounted for within the study budget. Supportive therapies will be considered for funding under all of the following circumstances:

Funding will only be considered for ODB eligible recipients (must be ODB eligible at the time of enrolment in the trial)

Funding will only be considered for products currently funded by the OPDP according to their approved criteria.

The EAP request should indicate that the requested product is being used as supportive therapy as part of a clinical trial.

Manufacturer sponsored trials will be excluded, and it is expected that manufacturers will provide funding for study treatments as part of the trial budget. For trials that are not manufacturer sponsored, investigators are asked to provide prior notification to the ministry of impending requests for funding of supportive therapies for a clinical trial. Requestors should indicate trial details, funding details, patient numbers, and timelines for their request prior to submitting the first request to EAP. Please contact an EAP Operations Manager at the address below.

Inquiries regarding the Exceptional Access Program should be directed to: